Welcome Karin Westermark! On February 1, you joined our team as senior consultant in medical devices. What is your background, prior to joining RegSmart? Most recently, I worked at the Medical Device department at the Swedish Medical Products Agency (MPA) for six years – first as Assessor and the last three years as Senior Assessor … Continue reading Welcome to RegSmart, Karin Westermark, senior consultant medical devices
Most welcome, Gunilla Nygård! On January 10, you joined RegSmart as senior project management consultant, adding a new service and key competence to our team of senior regulatory experts. What is your background? I have almost twenty years of experience from global drug development and project delivery at Astra Zeneca, from early phase to approval … Continue reading Welcome to Regsmart, Gunilla Nygård, senior project leader
It has been a year of covid-19 and pandemic restrictions, home offices and digital meetings. But for RegSmart, despite of all challenges, it has been a year of growth and development in many ways. Let us summarize. From 4 to 8 senior consultants – with expanded medical device services We have recruited and sharpened our … Continue reading What happened in the RegSmart year of 2021?
Sara is an expert in clinical documentation under the new medical device regulation (MDR) and in biomaterials. Before joining RegSmart, Sara has held senior scientist positions in academia and industry for 7 years. Her main focus has been the transition from MDD to MDR compliance of clinical evaluation, post market surveillance, post market clinical follow-up (PMCF), … Continue reading Welcome to RegSmart, Sara Gallinetti, senior consultant, medical devices and biomaterials
Sophie is an expert on chemical/pharmaceutical aspects of drug development. Most recently, Sophie comes from the Swedish Medical Products Agency (MPA), where she spent four years as a chemistry and pharmaceutical assessor. Her responsibilities included provision of scientific advice, review of clinical trial applications as well as market authorization applications and variations. She has over 15 … Continue reading Welcome to RegSmart, Sophie Bertilsson, senior consultant, CMC and pharmaceutical development
Brita is an expert in medical device regulations (MDD/MDR) and has a long experience of use and maintenance of medical devices in the health care environment. She has a long regulatory background and has worked for the Swedish Medical Products Agency (MPA) for the last 12 years. Brita has worked with inspections of manufacturers, and … Continue reading Welcome to RegSmart, Brita Liljestrand, senior consultant in medical devices!
Center for Translational Research Sweden AB (CTR) acquires Toxicology Knowledge Team Sweden AB (TKT) further strengthening the CTR group with optimised toxicological support. From April 1, TKT is a fully owned subsidiary to the holding company CTR. The activities at TKT will continue without interruption and with the same staff, in the same facilities in … Continue reading CTR acquires preclinical toxicology company
Welcome to RegSmart, Katarina Andersson, senior consultant! Our new senior consultant Katarina has a long-standing experience as a pharmaceutical inspector, pharmacovigilance (GVP). Most recently, Katarina comes from the Swedish Medical Products Agency (MPA), where she spent twelve years as an inspector, whereof the last six years as Head of the GVP/GCP group of inspectors. She … Continue reading New senior consultant: Katarina Andersson
Our new senior consultant Robert is a pharmacist with a PhD in medical cell biology. Most recently, Robert comes from the Swedish Medical Products Agency, where he spent eight years as a clinical assessor. As a clinical assessor he has reviewed a number of market authorisation applications as well as providing scientific advice to companies. … Continue reading Welcome to RegSmart, Robert Hägerkvist, senior consultant!
CTR tillkännager att styrelsen har utsett Karin Meyer till ny verkställande direktör. Karin Meyer efterträder Mats Lindquist som varit verkställande direktör sedan starten av CTR 2016. Karin Meyer har en lång erfarenhet av ledande befattningar inom läkemedels- och biotechindustrin, god branschkännedom och en mycket god förståelse för utveckling av nya produkter inom dessa områden. Karin, … Continue reading Karin Meyer blir ny VD för Center for Translational Research Sweden AB (CTR)
